BOSTON, Massachusetts – May 7th 2024 – Cycle Pharmaceuticals Limited (Cycle) is pleased to announce the launch of tiopronin delayed-release tablets as a treatment option for patients with cystinuria.1 Tiopronin delayed-release tablets are available in 100 mg and 300 mg doses, and are approved by the US Food and Drug Administration (FDA).1 Generic tiopronin delayed-release tablets must be taken without food.1

Cystinuria is the most common inheritable cause of kidney stone disease. Incidence of the condition is estimated to be 1 in 7,000 worldwide.2

The launch of tiopronin delayed-release tablets is a partnership between Cycle and Torrent Pharma Inc. (Torrent) utilizing Anovo Specialty Pharmacy (Anovo) in which all three companies are committed to providing patients with rare diseases the medication and patient support they need.

Tiopronin delayed-release tablets are a treatment option for patients with cystinuria who want to benefit from the support services provided by Cycle Vita™, a dedicated support platform which provides individualized product support* for patients, and ongoing dispensing and support services provided by Anovo, the exclusive specialty pharmacy for this product.

“Cystinuria is a chronic lifelong condition in which stones commonly reoccur.3 In addition, close control of a patient’s diet, specifically a reduction in salt and methionine intake, can have an impact on the likelihood of stones forming.3 We are fully aware of the unique personal challenges these patients face in effectively managing their cystinuria. That’s why we’re providing individualized support including a Bridge Program* and Co-pay Assistance Program*. In addition, a Patient Nutrition Program* will be available to reinforce the clinic’s nutrition plan,” says Chikai Lai, SVP & Chief Commercial Officer, Cycle.

Tiopronin delayed-release tablets are Cycle’s fifth commercial product to be launched in the US, building on the launch of:

  • NITYR® (nitisinone) Tablets in 2017
  • SAJAZIR™ (icatibant) Injection in 2021
  • JAVYGTOR™ (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solu-tion in 2022; and
  • TASCENSO ODT® (fingolimod) in 2023

Tiopronin delayed-release tablets are indicated in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Tiopronin delayed-release tablets must be taken without food.1

To find out more about Cycle Vita, please visit www.cyclevita.life or call +1 (888) 360-8482 and find the Full Prescribing Information available at www.tiopronin.us/PI.

Important Safety Information
Important Safety Information is below. Full Prescribing Information is available at www.tiopronin.us/PI.

INDICATIONS
Tiopronin delayed-release tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for prevention of cystine stone formation in adult and pediatric patients 9 years of age and older with severe homozygous cystinuria who are not responsive to these measures alone.

WARNINGS AND PRECAUTIONS
Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria.
Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported.

MOST COMMON ADVERSE REACTIONS
Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis.

DRUG INTERACTIONS
Alcohol: Tiopronin is released faster from tiopronin delayed-release tablets in the presence of alcohol and the risk for adverse events associated with tiopronin delayed-release tablets when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking tiopronin delayed-release tablets.

USE IN SPECIFIC POPULATIONS:
Pregnancy: Available published case report data with tiopronin have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Renal stones in pregnancy may result in adverse pregnancy outcomes. Tell your healthcare provider immediately if you become pregnant or planning to become pregnant.

Lactation: There are no data on the presence of tiopronin in either human or animal milk or on the effects of the breastfed child. A published study suggests that tiopronin may suppress milk production. Because of the potential for serious adverse reactions, including nephrotic syndrome, advise patients that breastfeeding is not recommended during treatment with tiopronin delayed-release tablets. Tell your healthcare provider immediately if you plan on breast feeding.

Pediatric Use: Tiopronin delayed-release tablets are indicated in pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation who are not responsive to these measures alone.

Tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg or in pediatric patients unable to swallow tablets.
Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

For more detailed information, please refer to the full Prescribing Information at www.tiopronin.us/PI.

If you get any side effects, talk to your healthcare provider. This includes possible side effects not listed in this material. You may also report side effects directly by calling Torrent Pharma Inc. at: 1-800-912-9561 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

This material is for education purposes only. It is not intended to be, and should not be used as, a substitute for medical advice.
US-TIO-2400004 (February 2024)

References

1. Tiopronin Delayed-Release Tablets. Prescribing Information. Torrent Pharma Inc.
2. Leslie, S.W., Sajjad, H. and Nazzal, L. (2023). Cystinuria. [online] Nih.gov. Available at: https://www.ncbi.nlm.nih.gov/books/NBK470527/ [Accessed Feb 9 2024].
3. Cystinuria UK – Diet – what should I eat (2023). Cystinuria UK – Diet – what should I eat? [online] Cystinuriauk.co.uk. Available at: https://www.cystinuriauk.co.uk/diet—what-should-i-eat [Accessed Feb 9 2024].

* Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at +1 (888) 360-8482.

The US Prescribing Information provides the indications for which the product is approved in the US. Please consult the US Prescribing Information and product labeling for information about the specific uses for which the product is indicated in the US.

–ENDS–

Cycle Vita™, SAJAZIR™ and JAVYGTOR™ are trademarks of Cycle Pharmaceuticals Limited in the United States. NITYR® is a registered trademark of Cycle Pharmaceuticals Limited in the United States. TASCENSO ODT® is a registered trademark of Handa Neuroscience, LLC.
©2024 Cycle Pharmaceuticals Limited. All rights reserved.

About Cycle Pharmaceuticals
Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease patient community. Cycle focuses on rare metabolic, immunological, and neurological genetic conditions. Within neurological conditions, we focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit www.cyclepharma.com and follow us on X, LinkedIn and Facebook.

About Torrent Pharma Inc.
Torrent Pharma is one of the leading Pharma companies in India. Torrent is the pioneer in initiating the concept of niche marketing in India and today is ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC). Torrent also has significant presence in diabetology, pain management, gynecology, oncology and anti-infective segments.

Torrent Pharma is present in more than 40 countries. It is ranked first amongst Indian Companies for having largest market share in Brazil and Germany.

About Anovo
Anovo was founded in 2012 as an exclusive provider of comprehensive end-to-end services for manufacturers of rare disease drugs and patients who need the drugs, including specialty wholesale/3PL distribution services, specialty pharmacy services, and patient support hub programs.
Anovo benefits all parties involved by navigating all the complexities of managing rare disease medications and providing the related support needed by patients, caregivers and prescribers.

FOR FURTHER INFORMATION PLEASE CONTACT
Marketing@cyclepharma.com
Cycle Pharmaceuticals
Tel: +44 1223 354 118